Kaizen For Pharmaceutical Medical Device And Biotech Industries

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Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Author : Shruti Bhat
Publisher :
ISBN 13 : 9781520947846
Total Pages : 309 pages
Book Rating : 4.9/5 (478 download)

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Book Synopsis Kaizen for Pharmaceutical, Medical Device and Biotech Industries by : Shruti Bhat

Download or read book Kaizen for Pharmaceutical, Medical Device and Biotech Industries written by Shruti Bhat and published by . This book was released on 2017-03-31 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen practices from auto sector won't work for pharmaceutical, medical device, and biotech organizations. Kaizen needs to be customized for these life science industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized for such industries.For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 250 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals NHP, medical devices, biotech and healthcare sectors, and felt it will be beneficial to share those techniques and experiences.Some salient features of this book:* This book presents useful ideas that one can implement immediately, often at no additional cost. * It shows how to transform a business from 'good- to- great'. True benefits of Kaizen implementation are realized because it adds value to your products, increases market share, and drives both top and bottom lines of your business. * It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations, conduct successful scale-up and technology transfer to manufacturing sites.* It shows the company's senior management, how to use Kaizen to increase ROI (return on investment) while complying with cGMP (current Good Manufacturing Practices) and other regulations, address any rising competition and counteract fluctuating market economy. * Kaizen has mainly been used in Japan and many other SE Asian companies and in Europe. Up until now, it has not gained enough significance in North America, because of which it has not been utilized to its full potential. The root cause is the difference in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap and presents Kaizen methodology for direct implementation within any pharmaceutical, medical device or biotech company; in east or west.* This book can also be an excellent resource for Kaizen beginners with a lot of real life industry examples, case studies and several 'do-it-yourself' exercises, which is of tremendous value, in absence of a Kaizen coach.In addition to explaining all the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device and biotech companies. This book will be most applicable to small to medium-size companies. It will demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech and all life sciences organizations, irrespective of their size or workplace culture. It will also provide practical and useful examples and case studies of Kaizen principles that can be executed at various levels across the organization as well as for yourself as an individual to further your personal career. And last but not the least, it will help to improve revenues and create a lasting profitable change by using Kaizen principles and techniques.

Validation Standard Operating Procedures

Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1420009419
Total Pages : 1144 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Validation Standard Operating Procedures by : Syed Imtiaz Haider

Download or read book Validation Standard Operating Procedures written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2006-05-30 with total page 1144 pages. Available in PDF, EPUB and Kindle. Book excerpt: Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Applying Lean Six Sigma in the Pharmaceutical Industry

Author : Bikash Chatterjee
Publisher : CRC Press
ISBN 13 : 1317180097
Total Pages : 242 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Applying Lean Six Sigma in the Pharmaceutical Industry by : Bikash Chatterjee

Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 1439886903
Total Pages : 586 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Quality Operations Procedures for Pharmaceutical, API, and Biotechnology by : Syed Imtiaz Haider

Download or read book Quality Operations Procedures for Pharmaceutical, API, and Biotechnology written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2012-06-06 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.

Pharmaceutical and Biomedical Project Management in a Changing Global Environment

Author : Scott D. Babler
Publisher : John Wiley & Sons
ISBN 13 : 1118058216
Total Pages : 277 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Pharmaceutical and Biomedical Project Management in a Changing Global Environment by : Scott D. Babler

Download or read book Pharmaceutical and Biomedical Project Management in a Changing Global Environment written by Scott D. Babler and published by John Wiley & Sons. This book was released on 2011-01-06 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.

Medical Device Quality Management Systems

Author : Susanne Manz
Publisher : Academic Press
ISBN 13 : 0128142227
Total Pages : 298 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Medical Device Quality Management Systems by : Susanne Manz

Download or read book Medical Device Quality Management Systems written by Susanne Manz and published by Academic Press. This book was released on 2018-09-27 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Author : Anurag S. Rathore
Publisher : CRC Press
ISBN 13 : 1439850933
Total Pages : 535 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals, Third Edition by : Anurag S. Rathore

Download or read book Process Validation in Manufacturing of Biopharmaceuticals, Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

We Don't Build Cars; The Art of Sustained Competitive Improvement in the Drug and Medical Device Industries

Author : William Botha
Publisher : Lulu.com
ISBN 13 : 1257846272
Total Pages : 136 pages
Book Rating : 4.2/5 (578 download)

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Book Synopsis We Don't Build Cars; The Art of Sustained Competitive Improvement in the Drug and Medical Device Industries by : William Botha

Download or read book We Don't Build Cars; The Art of Sustained Competitive Improvement in the Drug and Medical Device Industries written by William Botha and published by Lulu.com. This book was released on 2012-11-28 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: An incisive and value-packed insight into the practical application of the Toyota Production System (or Lean) within the biopharmaceutical, pharmaceutical and medical devices industries. Written by a gifted trainer and leader in the niche, it is filled with tricks and traps on how best to navigate the treacherous minefield of regulations while generating significant and sustained benefit to the business and the patient. The Leanership model; integrating dynamic leadership behaviors with robust control systems and effective TPS tools, is described within the covers. The author, as a result of his time as a leader, manager, trainer and consultant is able to tell relevant personal stories to illuminate the key concepts and philosophies that will enable the reader to replicate his results. Illustrated with profound quotes from world leaders and salted with a quirky sense of humor, this treasure of a work is an easy, fast read.

Quality Systems and Controls for Pharmaceuticals

Author : Dipak Kumar Sarker
Publisher : John Wiley & Sons
ISBN 13 : 0470773049
Total Pages : 204 pages
Book Rating : 4.4/5 (77 download)

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Book Synopsis Quality Systems and Controls for Pharmaceuticals by : Dipak Kumar Sarker

Download or read book Quality Systems and Controls for Pharmaceuticals written by Dipak Kumar Sarker and published by John Wiley & Sons. This book was released on 2008-07-31 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Systems and Control for Pharmaceuticals is an accessible overview of the highly-regulated area of pharmaceutical manufacture, the production of biomedical materials, and biomedical devices. Introducing the subject in a clear and logical manner it enables the reader to grasp the key concepts of the multidisciplinary area of control science and specifically quality control using industrial and theoretical models. Taking a multidisciplinary approach to the subject the reader is guided through key topics such as product safety which takes into account aspects of analytical science, statistics, microbiology, biotechnology, engineering, business practice and optimizing models, the law and safeguarding public health, innovation and inventiveness and contemporary best practice. The author has both industry and academic experience and many ‘best practice’ examples are included throughout the text based on his own industry experience and current practicing industrial pharmacists. This is an invaluable reference for all students of pharmacy who may have little or no familiarity with industrial practice and for those studying BSc chemistry, biomedical sciences, process analytical chemistry and MSc in Industrial Practice.

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

Author : Nuala Calnan
Publisher : CRC Press
ISBN 13 : 1315351366
Total Pages : 357 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry by : Nuala Calnan

Download or read book A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry written by Nuala Calnan and published by CRC Press. This book was released on 2017-06-26 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

Lean Biomanufacturing

Author : Nigel J Smart
Publisher : Elsevier
ISBN 13 : 1908818409
Total Pages : 384 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis Lean Biomanufacturing by : Nigel J Smart

Download or read book Lean Biomanufacturing written by Nigel J Smart and published by Elsevier. This book was released on 2013-10-31 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. A focus on the issues associated with the application of lean principles to biomanufacturing Practical examples of factors which can affect biopharmaceutical processes Coverage of key factors which require integration to run an efficient biopharmaceutical process

Quality by Design for Biopharmaceuticals

Author : Anurag S. Rathore
Publisher : John Wiley & Sons
ISBN 13 : 1118210913
Total Pages : 279 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Quality by Design for Biopharmaceuticals by : Anurag S. Rathore

Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Manufacturing of Pharmaceutical Proteins

Author : Stefan Behme
Publisher : John Wiley & Sons
ISBN 13 : 3527349472
Total Pages : 422 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Manufacturing of Pharmaceutical Proteins by : Stefan Behme

Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2022-04-18 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: An expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization. The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers: A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics Comprehensive explorations of the technology of the manufacturing process and analytics Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.

Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Author : Shruti Bhat
Publisher : ISBN Canada
ISBN 13 : 9781988663043
Total Pages : pages
Book Rating : 4.6/5 (63 download)

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Book Synopsis Kaizen for Pharmaceutical, Medical Device and Biotech Industries by : Shruti Bhat

Download or read book Kaizen for Pharmaceutical, Medical Device and Biotech Industries written by Shruti Bhat and published by ISBN Canada. This book was released on 2017-04-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen practices from auto sector won't work for pharmaceutical, medical device, and biotech organizations. Kaizen needs to be customized for these life science industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized for such industries. For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 250 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals NHP, medical devices, biotech and healthcare sectors, and felt it will be beneficial to share those techniques and experiences. In addition to explaining all the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device and biotech companies. This book will be most applicable to small to medium-size companies. It will demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech and all life sciences organizations, irrespective of their size or workplace culture. It will also provide practical and useful examples and case studies of Kaizen principles that can be executed at various levels across the organization as well as for yourself as an individual to further your personal career. And last but not the least, it will help to improve revenues and create a lasting profitable change by using Kaizen principles and techniques.

Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry

Author : Carrillo-Cedillo, Eugenia Gabriela
Publisher : IGI Global
ISBN 13 : 1799896153
Total Pages : 298 pages
Book Rating : 4.7/5 (998 download)

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Book Synopsis Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry by : Carrillo-Cedillo, Eugenia Gabriela

Download or read book Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry written by Carrillo-Cedillo, Eugenia Gabriela and published by IGI Global. This book was released on 2022-03-18 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.

Quality Control Training Manual

Author : Syed Imtiaz Haider
Publisher : CRC Press
ISBN 13 : 143985016X
Total Pages : 484 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Quality Control Training Manual by : Syed Imtiaz Haider

Download or read book Quality Control Training Manual written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2016-04-19 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences

Safety Evaluation of Pharmaceuticals and Medical Devices

Author : Shayne C. Gad
Publisher : Springer
ISBN 13 : 9781441974501
Total Pages : 126 pages
Book Rating : 4.9/5 (745 download)

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Book Synopsis Safety Evaluation of Pharmaceuticals and Medical Devices by : Shayne C. Gad

Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer. This book was released on 2011-07-21 with total page 126 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.